DECA-DURABOLIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for DECA-DURABOLIN (DECA-DURABOLIN).
Nandrolone decanoate is an anabolic steroid that binds to androgen receptors, increasing protein synthesis and promoting muscle growth. It also stimulates erythropoietin production, increasing red blood cell mass.
| Metabolism | Primarily hepatic via reduction, hydroxylation, and conjugation; major metabolites include 19-norandrosterone and 19-noretiocholanolone; metabolized by 5α-reductase and 3β-hydroxysteroid dehydrogenase. |
| Excretion | Primarily renal (90% as metabolites, 5% unchanged); fecal elimination accounts for <5%. |
| Half-life | Terminal half-life of nandrolone decanoate is 4.3 hours for the decanoate ester, but the active metabolite nandrolone has a prolonged half-life of 6-7 days due to slow release from intramuscular depot and enterohepatic recirculation; clinical effects persist for 3-4 weeks. |
| Protein binding | Approximately 95% bound to sex hormone-binding globulin (SHBG) and albumin. |
| Volume of Distribution | Vd approximately 1.2 L/kg; indicates extensive tissue distribution, particularly to muscle and adipose tissue. |
| Bioavailability | Oral: <3% due to extensive first-pass metabolism; intramuscular: 100%. |
| Onset of Action | Intramuscular: 2-5 days for anabolic effects, 7-10 days for erythropoietic stimulation. |
| Duration of Action | Intramuscular: Up to 3-4 weeks after single dose due to slow release from depot; clinical monitoring recommended every 2-3 weeks. |
Intramuscular injection of 100-200 mg every 1-3 weeks for anabolic effects; for replacement therapy, 50-100 mg every 2-4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with severe renal impairment (GFR <30 mL/min); for moderate impairment (GFR 30-59 mL/min), reduce dose by 50% and monitor fluid retention. |
| Liver impairment | Contraindicated in Child-Pugh class C; for class B, use with caution and reduce dose by 50%; no adjustment needed for class A. |
| Pediatric use | Not recommended for growth promotion; weight-based dosing not established due to risk of premature epiphyseal closure. |
| Geriatric use | Use lower initial doses (e.g., 50 mg IM every 3-4 weeks) due to higher risk of prostatic hypertrophy, fluid retention, and cardiovascular effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for DECA-DURABOLIN (DECA-DURABOLIN).
| Breastfeeding | Nandrolone decanoate is excreted in breast milk; M/P ratio not reported. Potential for androgenic effects in nursing infants (e.g., virilization). Use is contraindicated during breastfeeding due to risk of adverse effects. |
| Teratogenic Risk | Androgenic steroids, including nandrolone decanoate, are contraindicated in pregnancy due to virilization of female fetuses. First trimester: risk of clitoromegaly, labial fusion, urogenital sinus abnormalities. Second/third trimester: risk of clitoral enlargement, advanced bone age, growth restriction. High risk of teratogenicity throughout pregnancy. |
■ FDA Black Box Warning
Anabolic steroids, including nandrolone decanoate, may cause peliosis hepatis, liver cell tumors, and blood lipid changes associated with increased cardiovascular risk. They are not approved for enhancing athletic performance and should not be used for this purpose.
| Common Effects | Edema swelling Nausea Breast enlargement Acne |
| Serious Effects |
Known hypersensitivity, prostate cancer, breast cancer in males, pregnancy, nephrotic syndrome, and hypercalcemia.
| Precautions | Hepatotoxicity (peliosis hepatis, hepatocellular carcinoma), lipid profile changes (decreased HDL, increased LDL), cardiovascular risk, exacerbation of prostate cancer, virilization in women, premature epiphyseal closure in children, glucose intolerance, and edema. |
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| Fetal Monitoring | If inadvertent exposure during pregnancy: serial ultrasound for fetal growth, anatomy, and amniotic fluid index. Consider fetal karyotyping if phenotypic abnormalities suspected. Monitor maternal liver function, lipid profile, and blood glucose due to metabolic effects. |
| Fertility Effects | In males: suppression of spermatogenesis, decreased libido, and impotence due to negative feedback on gonadotropins; effects may persist after discontinuation. In females: menstrual irregularities, anovulation, and reversible infertility. Chronic use may lead to persistent reproductive dysfunction. |